lamotrigine

Generic: lamotrigine

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lamotrigine
Generic Name lamotrigine
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

lamotrigine 25 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 51672-4130
Product ID 51672-4130_44812d3c-0fc0-67dd-e063-6394a90a9d70
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078525
Listing Expiration 2026-12-31
Marketing Start 2009-01-27

Pharmacologic Class

Established (EPC)
anti-epileptic agent [epc] mood stabilizer [epc]
Mechanism of Action
organic cation transporter 2 inhibitors [moa] dihydrofolate reductase inhibitors [moa]
Physiologic Effect
decreased central nervous system disorganized electrical activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 516724130
Hyphenated Format 51672-4130

Supplemental Identifiers

RxCUI
198427 198428 198429 282401
UPC
0351672413019 0351672413347 0351672413248 0351672413118
UNII
U3H27498KS
NUI
N0000175753 N0000008486 N0000175751 N0000187061 N0000000191

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name lamotrigine (source: ndc)
Generic Name lamotrigine (source: ndc)
Application Number ANDA078525 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 CARTON (51672-4130-0) / 10 TABLET in 1 BLISTER PACK
  • 100 TABLET in 1 BOTTLE (51672-4130-1)
  • 1000 TABLET in 1 BOTTLE (51672-4130-3)
  • 60 TABLET in 1 BOTTLE (51672-4130-4)
  • 30 TABLET in 1 BOTTLE (51672-4130-6)
source: ndc

Packages (5)

51672-4130-0 10 BLISTER PACK in 1 CARTON (51672-4130-0) / 10 TABLET in 1 BLISTER PACK 51672-4130-1 100 TABLET in 1 BOTTLE (51672-4130-1) 51672-4130-3 1000 TABLET in 1 BOTTLE (51672-4130-3) 51672-4130-4 60 TABLET in 1 BOTTLE (51672-4130-4) 51672-4130-6 30 TABLET in 1 BOTTLE (51672-4130-6)

Ingredients (1)

lamotrigine (25 mg/1)

Linked Drug Pages (1)

Lamotrigine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "44812d3c-0fc0-67dd-e063-6394a90a9d70", "openfda": {"nui": ["N0000175753", "N0000008486", "N0000175751", "N0000187061", "N0000000191"], "upc": ["0351672413019", "0351672413347", "0351672413248", "0351672413118"], "unii": ["U3H27498KS"], "rxcui": ["198427", "198428", "198429", "282401"], "spl_set_id": ["b829f9b2-f0ac-408a-a6f4-18b72150227d"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]", "Mood Stabilizer [EPC]"], "pharm_class_moa": ["Organic Cation Transporter 2 Inhibitors [MoA]", "Dihydrofolate Reductase Inhibitors [MoA]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (51672-4130-0)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "51672-4130-0", "marketing_start_date": "20090127"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (51672-4130-1)", "package_ndc": "51672-4130-1", "marketing_start_date": "20090127"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (51672-4130-3)", "package_ndc": "51672-4130-3", "marketing_start_date": "20090127"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (51672-4130-4)", "package_ndc": "51672-4130-4", "marketing_start_date": "20090127"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (51672-4130-6)", "package_ndc": "51672-4130-6", "marketing_start_date": "20090127"}], "brand_name": "Lamotrigine", "product_id": "51672-4130_44812d3c-0fc0-67dd-e063-6394a90a9d70", "dosage_form": "TABLET", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]", "Dihydrofolate Reductase Inhibitors [MoA]", "Mood Stabilizer [EPC]", "Organic Cation Transporter 2 Inhibitors [MoA]"], "product_ndc": "51672-4130", "generic_name": "Lamotrigine", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lamotrigine", "active_ingredients": [{"name": "LAMOTRIGINE", "strength": "25 mg/1"}], "application_number": "ANDA078525", "marketing_category": "ANDA", "marketing_start_date": "20090127", "listing_expiration_date": "20261231"}